NCT06811246

A Clinical Study of Islatravir and Its Interaction With Lamivudine (MK-8591-058)

An Open-Label Study to Evaluate the Effect of Multiple Doses of Lamivudine on the Single Dose Pharmacokinetics of Islatravir in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to learn what happens to the medication islatravir (ISL), in a healthy person's body over time--called a pharmacokinetic (PK) study. Researchers want to compare the amount of islatravir in the blood when it is taken alone as a single dose and when it is taken with multiple doses of another medication called lamivudine (3TC).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Islatravir (ISL)	Oral administration of a single dose in period 1 and period 2
DRUG	Lamivudine (3TC)	Oral administration of multiple daily doses for 27 days

Timeline

• Start date: 2024-02-07
• Primary completion: 2024-07-14
• Completion: 2024-07-14
• First posted: 2025-02-06
• Last updated: 2025-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study